UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007634 |
|---|---|
| Receipt number | R000008857 |
| Scientific Title | Effect of angiotensin receptor blockers for neointimal coverage after stent implantation. |
| Date of disclosure of the study information | 2012/04/02 |
| Last modified on | 2015/10/01 10:32:26 |
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Basic information
Public title
Effect of angiotensin receptor blockers for neointimal coverage after stent implantation.
Acronym
Effect of angiotensin receptor blockers for neointimal coverage after stent implantation.
Scientific Title
Effect of angiotensin receptor blockers for neointimal coverage after stent implantation.
Scientific Title:Acronym
Effect of angiotensin receptor blockers for neointimal coverage after stent implantation.
Region
| Japan |
Condition
Condition
Hypertensive patients with coronary arteries disease.
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of olmesaltan for neointimal coverage after after implantation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stents stenosis rate with optical coherence tomography
Key secondary outcomes
Target vessel revascularization, changes in high-sensitivity CRP ,changes in angiotensin 2
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Olmesartan Group
Interventions/Control_2
Non- Olmesartan Group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Patient between 20 and 90 years old, with hypertension
(2) Patients with coronary stenosis or coronary artery occlusion undergoing PCI
(3) Patients who have a de novo lesion to be treated bare-metal stent implantation.
(4)Patient who has agreed to undergo all clinical follow ups listed in the present protocol.
(5)Patients who has agreed to conditions after receiving an explanation about the contents of the present clinical study and who has signed the consent form approved by the ethical review board at each study site.
Key exclusion criteria
(1) Patients who had cerebral accident in the past 12 weeks
(2) Patients with acute ST-segment elevation myocardial infarction
(3) Old myocardial infarction.
(4) Heart failure (LVEF < 45%)
(5) Active myocarditis
(6) Active pericardium flame
(7) A cardiac transplantation(<=6months)
(8) Diabetes mellitus
(9) Proteinuria
(10)Chronic renal dysfunction (eGFR<=60mL/min/1.73 m2)
(11) patient who has a bad prognosis's disease from angina
(12) Restenosis
(13)Chronic total coronary artery occlusion
(14) The target lesion is located in or supplied by an arterial or venous bypass graft
(15) The target lesion is located in left main trunk.
(16) Vessel diameter<2mm
(17) Systolic blood pressure is under 100 mmHg
(18)Serum creatinine>1.8 mg/dl
(19) Serum potassium>5.5mEq/L
(20) Altered hepatic function (serum aspartate aminotransferase or alanine
aminotransferase >= 3-folds of standard value in each institute)
(21)Definite or provisional diagnosis of renal artery stenosis
(22)Patients who meet contraindication of vasoconstrictor
(23) Severe valvular heart disease
(24) Women who are pregnant or lactating, or of child bearing potential, or with a desire to be a parent during the study period.
(25)A psychiatric disorder and legal disability
(26) Drug or alcohol addiction(<=2years)
(27) Other patients judged as being inappropriate for the subjects of the study by investigators
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromasa Otake |
Organization
Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-5846
hkinutani@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromasa Otake |
Organization
Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
Address
7-5-1 Chuou-ku, Kusunoki-cho, Kobe
TEL
078-382-5846
Homepage URL
hkinutani@hotmail.com
Sponsor or person
Institute
Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
神戸大学附属病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2012 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 01 | Day |
Last modified on
| 2015 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008857
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